FSP Assistant, CRA

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Perform remote activities on assigned projects in liaison with the CRA and study Clinical Lead • Support site preparedness and the logistical aspects of the monitoring process • Assist with site management and remote monitoring in accordance with SOPs and regulatory guidelines • Complete study and site management activities defined in the task matrix • Complete and document study-specific training and learn study-specific systems • Provide in-house support during pre-study assessments and assessment waivers • Customize site ICFs with site contact details as needed • Perform remote review of EMR/EHR checklists and support applicable assessments • Verify document collection and RCR submission status; update site EDL and verify site information • Review patient-facing materials and translations • Support vendor-related qualification processes and site staff system access • Follow up on site staff training and coordinate logistics for IM attendance • Maintain vendor trackers and coordinate study/site supply management • Support essential document collection, review, and updating in systems • Follow up on missing vendor data such as ECGs, lab samples, and e-diaries • Support ongoing remote review of centralized monitoring tools • Support site payment processes, system updates, reconciliations, and invoice follow-up • Perform reconciliation tasks involving CRF and query status, deviations, SAEs, and safety reports • Verify document collection status and drive action for missing, incomplete, or expired documents • Perform other assigned site management tasks and client-requested FSP role activities • Complete administrative tasks including expense reports and timesheets

🎯 Requirements

• Bachelor's degree in a life science discipline or related field, or Registered Nursing certification, or equivalent relevant formal academic/vocational qualification • Previous experience providing the knowledge, skills, and abilities to perform the job, comparable to 0–2 years • Equivalency through a combination of appropriate education, training, and directly related experience may be considered • Previous experience supporting oncology studies • Basic medical and therapeutic area knowledge and understanding of medical terminology • Ability to attain and maintain working knowledge of ICH GCP, applicable regulations, and company procedural documents • Effective oral and written communication skills • Excellent interpersonal and customer service skills • Good organizational and time management skills and strong attention to detail • Ability to handle multiple tasks efficiently and effectively • Flexibility and adaptability • Ability to work in a team or independently • Well-developed critical thinking, root cause analysis, and problem-solving skills • Proficient computer skills and good knowledge of MS Office • Ability to learn and use appropriate software and leverage modern technology • Ability to extract pertinent information from study documents, electronic study data systems, CTMS, and dashboards • Excellent English language and grammar skills

🏖️ Benefits

• Fully remote work • Standard Monday–Friday work schedule • Home office environment • Equal opportunity employment • Reasonable accommodation for individuals with disabilities